As of July 2019, in the United States there have been a total of 25 biosimilar or follow-on biologic products approved by the US Food and Drug Administration (FDA). Of those, only 11 have been launched in the US market. The rate of FDA approval of biosimilars has increased in recent years, but uptake in the US market has been slow. There are lingering barriers to biosimilar utilization in the US including the effect of contract negotiations, patent litigation, and uncertainty among patients and prescribers reminiscent of the slow acceptance of generic small-molecule drugs in the 1980s. As biosimilars become more available in the US, decision-makers need more robust data, particularly reflecting real-world clinical practice to address concern over limitations of clinical trial data to support formulary decision-makers, clinicians, and patients in utilizing these new products. As biosimilar uptake increases gradually in the US, the potential for research is robust with available data and initiatives pursuing multi-source or large-scale observational research.
This webinar will provide an overview of the current state of biosimilars in the US, description of some barriers to utilization, discussion of real-world data and how stakeholders may use real-world evidence to inform treatment and coverage decisions, and an update on the efforts of the AMCP Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) to fill the information gap.ions